Universal Stylet Bougie in Patients With Cervical Neck Immobilization.

July 21, 2024 updated by: Moshira sayed mohamed, Theodor Bilharz Research Institute

Evaluating the Use of the Universal Stylet Bougie (USB) on Successful Intubation on the First Attempt Among Patients With Cervical Spine Immobilization by Using a Rigid Collar.

In patients with cervical spine injury, securing the airway while adequately immobilizing the cervical spine to avoid secondary neurological damage is very challenging. Although awake fiber-optic intubation is the most reliable method in patients with cervical trauma, it has some limitations such as lack of availability, need for expertise in the use, difficulty with non-cooperative patients, or presence of blood or secretions in the airway. Two devices are commonly used to facilitate tracheal intubation: a stylet or a tracheal tube introducer ("bougie").

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Universal Stylet Bougie, or USB™, represents a significant advance in the design and development of tracheal introducers (bougies) and stylets. Traditionally, the design requirements of styles and bougies have always been considered incompatible. A stylet requires sufficient rigidity to allow the tracheal tube to be manipulated to a variety of angles, whereas a bougie needs to be flexible enough to allow positive tracheal ring feedback to allow correct placement.

The unique design of the USB™ means the device can be used as a stylet or as a bougie. It consists of two metals inserted on both sides and a flexible middle section. The USB can easily be manipulated to a variety of angles when used as a stylet, yet has the flexibility when used as a bougie. In addition, the hexagonal shape provides less contact with the inner surface of the tracheal tube, providing particularly easy insertion and removal.

In this study we are simulating a difficult intubating condition by limiting the cervical neck extension through applying a rigid neck collar. Subsequently, we will assess whether using the USB device could improve the successful rate of intubation in these patients.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt, 02
        • Theodor Bilharz Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. ASA (American society of Anesthesiologists) physical status 1-2.
  2. Age 18- 60 years old of both sexes.
  3. Patients undergoing elective surgery under general anesthesia and tracheal intubation.

Exclusion Criteria:

  1. Age < 18 years and ≥ 60 years
  2. Pregnancy
  3. Patients with BMI >35 kg m-2
  4. Emergency surgery or full stomach
  5. Patients with suspected difficult airway {e.g., high neck circumference, airway masses, mouth scars, neck scars, or history of snoring).
  6. Patients with cervical spine pathology
  7. Patients with any cardiac disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: the Bougie group (group A)
Endotracheal intubation will be attempted using the video laryngoscope and the USB device will be used as a bougie.
Device: USB as a bougie
USB used as a bougie
Active Comparator: the stylet group ( B group)
Endotracheal intubation will be attempted using the video laryngoscope and using the USB device as a stylet.
Device: USB as a stylet
USB used as a bougie
No Intervention: the control group (C group)
Intubation of the trachea with an endotracheal tube will be attempted by using only the video laryngoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time required for intubation.
Time Frame: 30 seconds - 2 minutes
30 seconds - 2 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
number of attempts
Time Frame: 30 seconds to 2 minutes
30 seconds to 2 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theodor Bilharz Research Institute

Investigators

  • Principal Investigator: Moshira Amer, M.D., Theodor Bilharz Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

July 15, 2024

Study Registration Dates

First Submitted

July 21, 2024

First Submitted That Met QC Criteria

July 21, 2024

First Posted (Actual)

July 26, 2024

Study Record Updates

Last Update Posted (Actual)

July 26, 2024

Last Update Submitted That Met QC Criteria

July 21, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PT(823)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

data will be available upon request from the principal investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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